RecruitingNot Applicable

Evaluating Noninvasive Brain Stimulation for TMD Pain: A Feasibility Study

United States40 participantsStarted 2026-05-20

Plain-language summary

This study is a randomized, double-blind, sham-controlled feasibility trial designed to assess the acceptability and preliminary efficacy of Transcutaneous Auricular Neurostimulation (tAN) for individuals with Temporomandibular Disorders (TMD). Approximately 40 participants will be enrolled to evaluate whether daily, home-based tAN sessions-which deliver mild electrical pulses to the auricular branch of the vagus nerve-can effectively reduce chronic orofacial pain and improve associated cognitive and psychosocial dysfunctions. The study monitors feasibility through retention and adherence rates while tracking secondary outcomes such as pain intensity, cognitive flexibility, and mood changes using validated scales and wearable smartwatch data . Ultimately, this research aims to generate the critical data necessary to inform larger clinical trials and potentially offer a non-pharmacological, non-invasive treatment option for patients refractory to traditional TMD therapies.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18 to 65 years. * Diagnosis of temporomandibular disorder (TMD) based on the Diagnostic Criteria for Temporomandibular Disorders (DC-TMD). * Pain intensity of at least 4/10 on the Numeric Rating Scale (NRS) over the past two weeks. * Chronic pain duration of at least three months, consistent with diagnosis of chronic TMD. * Willingness to self-administer transcutaneous auricular nerve stimulation (tAN) at home and comply with study procedures. * Fluency in English to ensure comprehension of study materials and assessments. * Access to a smartphone or computer with internet to complete electronic study surveys and check-ins with the research team. Exclusion Criteria: * Neurological conditions that may interfere with study outcomes, including epilepsy, stroke, multiple sclerosis, or traumatic brain injury. * Use of implanted neuromodulation devices, such as vagus nerve stimulators, deep brain stimulators, or cochlear implants. * Unstable or severe psychiatric disorders, including active psychosis or severe depression with suicidal ideation. * Pregnancy or intention to become pregnant during the study period. * Skin conditions or other contraindications that prevent safe electrode placement on the auricular region (e.g., metal in the cymba concha that is unable or not willing to remove). * History of trauma (e.g., skull fracture) or periauricular surgery (e.g., temporomandibular joint replacement, acoustic neuroma removal) which would affect the loca…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Retention Rate

Timeframe: Week 6

Intervention Adherence

Timeframe: Week 4

Acceptability

Timeframe: Week 4

Trial details

NCT IDNCT07517172

SponsorUniversity of Minnesota

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09-30

Contact for this trial

Carla Campbell

612-625-6976 ohcrc@umn.edu

View on ClinicalTrials.gov More Temporomandibular Disorder trials